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Smartlock

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
SMARTLOCK FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Device Name
LOCKING L-PLATE, WITH 12MM BAR FDA UDI
Model / Reference
92-55767 FDA UDI
Description
LOCKING L-PLATE, WITH 12MM BAR FDA UDI

Identifiers

Catalog Number
92-55767 FDA UDI
Primary DI / UDI-DI
07613154131976 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Smartlock by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 2739ed02-dadb-4d46-a7b2-765d675b9016 35 fields · synced May 31, 2026